Pfizer Product License Support, Senior Associate in Collegeville, Pennsylvania
The Product License Support, Senior Associate, reporting through the US Compliance Team, will ensure Pfizer maintains compliance by delivering the portfolio of one or multiple applicable regulatory obligations. Product License Support Group comprises coordination of regulatory compliance starting at drug development stage and reaching through the lifespan of the Product.
The PLS Senior Associate for US Compliance is responsible for delivering all (A)NDA, BLA, and PMA annual reporting and drug listing activities required by the US Food and Drug Administration (FDA) to maintain active applications across Pfizer's entire portfolio (all business units). Our regulatory activities are driven by FDA guidance as well as internal policies and procedures focused on the US market.
PLS Senior Associate for US Compliance will focus on Annual Report includes compiling, authoring, and submission readiness of each submission.The PLS Senior Associate will also author Periodic Adverse Event Reports (PADER) labeling contributions.Drug listing responsibilities include NDC assignments, label publishing to Pfizer websites, creation and management of SPL (Structured Product Labeling), establishment and device registrations, and FDA User Fee activities (i.e.: PDUFA, GDUFA, BsUFA, and MDUFA).
The scope of work also expands into preparing and completing metadata submission to the GUDID Database to comply with FDA's UDI (Unique Device Identification) regulations, managing call for contributions for various Safety Aggregate reports, engaging the emerging markets.
Supports delivery of electronic and paper regulatory transactions and electronic review aids in support of Drug Listings, Drug Establishment Registrations, certificates and samples sourcing, XEVMPD submissions and other post market scheduled regulatory compliance activities in accordance with 21CFR 314.81.
Continuous Improvement of selected processes relating to human health submissions and selected drug and non-drug specific projects and related activities e.g. Drug listing and Establishment registrations,
Delivery of Product License Support Portfolio in a timely and quality manner.
Contributes to the completion of project tasks and/or milestones
Organizes own work to meet project task deadlines
Learns and applies basic team effectiveness skills (e.g., commitment, feedback, consensus management) within context of immediate Work Team.
Has fundamental knowledge of the principles and concepts of the discipline.
Applies technical skills to achieve assigned tasks
Contributes to the completion of routine Work Team related tasks.
Uses established procedures and methodologies.
Uses technical skills to achieve assigned regulatory operational responsibilities to support submissions to the Regulatory Authorities.
Applies fundamental knowledge of the relevant regulatory industry and local business environment.
Has fundamental knowledge of clinical, regulatory and/or other relative stakeholder groups.
Makes decisions that require choosing between limited options to resolve problems basic in their complexity
Performs work in a structured environment under direction from supervisor
Decisions impact own work and have limited effect on projects.
Decisions have limited effect on the delivery of scheduled work and may affect allocation of existing resources.
Exercises judgment to complete assigned tasks and has significant reliance on supervisor
Works in a structured environment under direct supervision
Uses established procedures to perform assigned tasks
Asks for guidance from other colleagues
Work is regularly reviewed for soundness of technical judgment, completeness, and accuracy.
Communicates straightforward information, asks questions and checks for understanding
Participates and contributes as a team member
Is responsible for certain team deliverables.
Implementation of solutions through interaction with other team members, and key contributors across sites, ensuring ability to maintain compliance with assigned processes and continuously improve on those processes
Participation on global/local teams to complete assignments and tasks within a specific task force/project. Contributes to the completion of moderately complex projects.
Liaison with internal stakeholders for issues regarding standards and processes, and drives resolution of these.
Utilization support of electronic technologies for submissions and tracking of documentation
Manages own time to meet agreed targets; develops plans for short-term work activities on own projects (timelines, work plans, deliverables) within a Work Team.
Applies technical skills and Work Team knowledge to achieve assigned work on projects/assignments
May act as a technical resource within own Work Team
Utilizes regulatory expertise, experience and technical skills to deliver on moderately complex tasks to support submissions to the Regulatory Authorities
Has a strong understanding of the relevant regulatory industry and local business environment.
Has strong understanding of clinical, regulatory and/or other relative stakeholder groups.
Works under general supervision. Performs assignments using established procedures and general instruction on the process and desired outcome
Uses a variety of communication tools and techniques to explain difficult issues and works to establish consensus
Undergraduate degree plus relevant experience as below, or
Demonstrated fluency with regulatory submissions publishing and understanding of application of technologies.
Demonstrated ability to function autonomously in a matrix environment.
Regulatory Expertise: Demonstrated knowledge of Regulatory compliance requirements, processes and systems
Demonstrated Project Managements Skills: Competent illustration of processes, tools and techniques for planning and monitoring multiple complex projects to established deadlines.
Technology: Experience and competency with Regulatory software, XML, Document Management, regulatory milestone reporting tools.
Functional/Technical Skills - has the functional and technical knowledge and skills to do the job at a high level of accomplishment
Acts Decisively - makes decisions in a timely manner, sometimes with incomplete information and under tight deadlines and pressure; able to make a quick decision
Seizes Accountability -will stand up and be counted; doesn't shirk personal responsibility; can be counted on when times are tough; willing to be the only champion for an idea or position; is comfortable working alone on a tough assignment
Change Agile - can effectively cope with change; can shift gears comfortably; can decide and act without having the total picture; isn't upset when things are up in the air; doesn't have to finish things before moving on; can comfortably handle risk and uncertainty
Peer Relationships- can quickly find common ground and solve problems for the good of all; can represent his/her own interests and yet be fair to other groups; can solve problems with peers with a minimum of noise; is seen as a team player and is cooperative; easily gains trust and support of peers; encourages collaboration; can be candid with peers
Influencing - Uses a range of effective communication styles and creates and inclusive environment with internal/external stakeholders to deliver goals and promote quality; uses diplomacy and tact and can diffuse high-tension situations comfortably.
Demonstrated knowledge of CFR as it relates to specific post-market submissions
Demonstrated knowledge of/experience with Pfizer Commercial Portfolio
Ability to communicate information and analyses to a variety of audiences both verbal and written format
Demonstration of processes, tools and techniques for planning and monitoring multiple projects to established deadlines.
Demonstrated coordination of activities in a highly regulated environment
Proven aptitude in project management and logistics
Demonstration of experience working in a challenging customer service environment
Proven experience managing or delivering through others in a team environment
Demonstrated attention to detail
Understanding of applicable filing regulatory guidelines and fluency regarding order and presentation of regional and national regulatory dossiers
Formal training in technical tools
Knowledge of drug development process
Work Location Assignment:Flexible
Relocation assistance may be available based on business needs and/or eligibility.
Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.
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EEO & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.
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